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FDA NDA · NDA210238

DOPTELET

avatrombopag maleate

Sponsor: AKARX INC

APPLICATION
NDA210238
TYPE
NDA
ORIGINAL APPROVAL
2018-05-21
LATEST ACTION
2025-07-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DOPTELET · ReferencePrescription
AVATROMBOPAG MALEATE EQ 20MG BASE · TABLET · ORAL

Approval history

2025-07-24Efficacy · Supplement 10 · standard — Letter ↗AP
2024-07-18Labeling · Supplement 9 · standard — Letter ↗AP
2021-10-14Labeling · Supplement 6 · standard — Label ↗AP
2020-08-20Labeling · Supplement 4 · standard — Label ↗AP
2019-06-26Efficacy · Supplement 1 · standard — Letter ↗AP
2019-03-21Labeling · Supplement 2 · standard — Label ↗AP
2018-05-21Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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